Senior Spinal Sustaining Engineer

Highridge Medical LLC; Westminster (CO); On-site; USD 85,000 - 100,000; Full time

Job summary

Highridge Medical LLC seeks a Sr. Sustaining Engineer I to drive technical support, maintenance, and continuous improvement of spinal implants, instruments, and systems throughout their lifecycle.

You will lead sustaining projects, partner with Quality, Regulatory, Manufacturing, and suppliers, and mentor junior engineers as needed. You will work with CAD/ SolidWorks, perform root cause analyses, and develop CAPAs while ensuring compliance with FDA and ISO 13485 standards.

Qualifications

• Minimum B.S. degree from an ABET-accredited school in Mechanical, Biomedical, Aerospace, or related fields.
• 3–7 years of relevant engineering experience, preferably in medical device sustaining/manufacturing.
• Preferred: spine or medical device experience including implants and instruments.

Responsibilities

• Lead sustaining projects for spinal implants and instruments from issue definition to closure.
• Provide day-to-day technical support to manufacturing and quality teams to maintain product availability.
• Lead or support root cause investigations and CAPAs using structured problem-solving and statistics.
• Create and manage engineering changes with updates to specs, drawings, and BOMs.
• Update CAD models and drawings; apply GD&T and manufacturability principles.
• Prepare verification, validation, and process validation documentation.

Skills

Root cause analysis

Project planning

Cross-functional collaboration

Structured problem-solving

Mentorship

Regulatory awareness

Education

ABET-accredited B.S. in Mechanical/Biomedical Engineering

Tools

SolidWorks

CAD drafting

GD&T

Microsoft Office

Statistical analysis software

Job description

Highridge Medical LLC seeks a Sr. Sustaining Engineer I to drive technical support, maintenance, and continuous improvement of spinal implants, instruments, and systems throughout their lifecycle.

You will lead sustaining projects, partner with Quality, Regulatory, Manufacturing, and suppliers, and mentor junior engineers as needed. You will work with CAD/ SolidWorks, perform root cause analyses, and develop CAPAs while ensuring compliance with FDA and ISO 13485 standards.